Pharma Stock Roundup: FDA Nod to Updated PFE, MRNA COVID Jabs, & More
This week, the FDA approved and the U.S. Centers for Disease Control and Prevention (CDC) recommended the broad use of updated COVID-19 vaccines of Pfizer PFE/BioNTech and Moderna MRNA. Novo Nordisk’s NVO board of directors approved the previously announced two-for-one split of its shares and American Depositary Receipts (ADR). AbbVie’s ABBV Skyrizi met both primary endpoints in a head-to-head study in Crohn’s disease. AstraZeneca’s AZN Fasenra met the primary endpoint in a late-stage study evaluating it for a new indication, eosinophilic granulomatosis with polyangiitis (EGPA).
Recap of the Week’s Most Important Stories
FDA Authorizes Pfizer, Moderna’s Updated COVID Jabs: The FDA authorized updated mRNA-based COVID-19 vaccines of Pfizer/BioNTech and Moderna to provide protection from the currently circulating strains of the COVID-19 virus. Pre-clinical/clinical data from studies on Moderna and Pfizer’s updated mRNA vaccines have shown improved neutralizing antibody responses against multiple circulating Omicron-related sublineages, including XBB.1.5, BA.2.86 (also called Pirola) and EG.5.1 (also called Eris). Moderna and Pfizer’s updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.
The CDC has also recommended for everyone 6 months and older to take the updated COVID shot. Pfizer and Moderna expect the vaccines to be launched in pharmacies, hospitals, and clinics across the United States this week. Americans who have health insurance will get this COVID-19 vaccine for free as most plans will cover the new vaccine.
Novo Nordisk Conducts 2:1 Stock Split: Novo Nordisk announced that its board of directors approved a two-for-one split of its shares (listed on Nasdaq Copenhagen) and ADRs (listed on NYSE). The stock split of Novo Nordisk B shares is effective from Sep 13, while that of ADRs will be effective on Sep 20. Therefore, the trading unit of the Novo Nordisk B shares listed on Nasdaq Copenhagen changed from DKK 0.20 to DKK 0.10. The ADRs will similarly be split. The stock split, announced in August along with the second quarter results, has been driven by the company’s success of obesity and diabetes drugs.
AstraZeneca’s EGPA Study on Fasenra Meets Goal: AstraZeneca’s asthma drug Fasenra met the primary endpoint in the phase III MANDARA study, evaluating it for treating EGPA. EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The MANDARA head-to-head study demonstrated non-inferior rates of remission of a single monthly injection of Fasenra to three injections per month of GSK’s Nucala (mepolizumab), which is the only current approved drug for EGPA. Fasenra is approved for treating severe eosinophilic asthma. Several label expansion studies are ongoing for Fasenra for eosinophil-driven diseases beyond severe asthma like nasal polyps, COPD, hypereosinophilic syndrome, bullous pemphigoid and others.
AbbVie’s Crohn’s Disease Head-To-Head Study on Skyrizi Meets Goals: AbbVie’s Skyrizi met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at week 48 versus J&J’s Stelara in a head-to-head study. The phase III study called SEQUENCE compared Skyrizi to Stelara for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNF therapies. Statistical significance was also achieved for all the study’s secondary endpoints for the superiority of Skyrizi over Stelara.
The NYSE ARCA Pharmaceutical Index rose 1.58% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks were in the green except Pfizer and AstraZeneca, with both declining 0.3%. AbbVie rose the most (up 3.3%),
Image Source: Zacks Investment Research
In the past six months, Lilly has risen the most (79.4%), while Pfizer has declined the most (15.1%).
(See the last pharma stock roundup here: J&J to End Hypertension Study & Other Regulatory Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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AstraZeneca PLC (AZN) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
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Moderna, Inc. (MRNA) : Free Stock Analysis Report
AbbVie Inc. (ABBV) : Free Stock Analysis Report
